Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

• Time required for the PAOP to be maintained at a value of
• less than or equal to 18 mm HG for at least four consecutive hours (+/- 30 minutes) during the intervention period.

• Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. [ Time Frame: Time from admission to endpoint achievement ] [ Designated as safety issue: No ]
• Total Volume Removal During the Intervention Period [ Time Frame: Intervention start to end. ] [ Designated as safety issue: No ]
• Volume Removal Rate. [ Time Frame: Intervention start to end. ] [ Designated as safety issue: No ]
  Hours of therapy required to remove 1 liter of fluid normalized to body weight.
• Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths [ Time Frame: Hospital discharge to 90 days after discharge ] [ Designated as safety issue: No ]
  Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.

The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.

This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.

• Heart Failure
• CHF

• Drug: IV loop diuretic
  Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
• Device: NxStage System One
  Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
  Other Name: NxStage System One

• Active Comparator: Ultrafiltration
  Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
  Intervention: Device: NxStage System One
• Active Comparator: Usual & Customary
  Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
  Intervention: Drug: IV loop diuretic

Inclusion Criteria:

• Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery catheter in situ
• Left ventricular ejection fraction <40%
• Mean Pulmonary Artery Occlusion Pressure ≥20 mm Hg
• Able to give informed consent

Exclusion Criteria:

• Currently on renal replacement therapy or determined to need renal replacement therapy at the time of enrollment
• Estimated glomerular filtration rate (GFR) <15 mL/min
• Systolic blood pressure (SBP) <80 mm Hg
• Acute coronary syndrome
• Hematocrit >50%
• Malignancy other than prostrate or skin
• Chronic edematous states other than HF, including nephritic syndrome and cirrhosis
• Chronic inflammatory or infectious condition
• Pregnancy
• Previous enrollment in this study
• Expectation of need for heart transplantation or cardiac assist device within one week
• Pulmonary failure requiring intubation and mechanical ventilation
• Known or suspected hypersensitivity to dialysis membranes
• Severe aortic stenosis or regurgitation
• Severe mitral stenosis